Cryoneedle

ABSTRACT

A cryoneedle comprises an outer tube having a distal section with a generally central gas supply line placed within the outer tube. The gas supply line supplies a cryogas for forming an iceball on an outer surface of the outer tube over the distal section. The gas supply line terminates in an expansion chamber placed within the distal section. The cryoneedle comprises a heat exchange helix contacting the inner surface of the outer tube. The heat exchange helix has an increasing surface area per unit distance of the distal section such that the iceball has a generally symmetric shape.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation application of U.S. application Ser.No. 14/627,568, now U.S. Pat. No. 10,390,871, filed Feb. 20, 2015 andtitled “CRYONEEDLE.” The entire content of this application isincorporated herein by reference.

FIELD

This disclosure generally relates to a cryoneedle for forming iceballshaving symmetric shapes.

BACKGROUND

Cryosurgical systems comprise one or more cryoneedle connected to one ormore cryogas sources. Such systems are described in thecommonly-assigned patent, U.S. Pat. No. 8,066,697 and in publishedapplication, U.S. Pub. No. 2010/0256620 A1, the disclosure of which ishereby incorporated by reference in its entirety. In such cryosurgicalsystems, a cryogas can be delivered from a cryogas source to one or morecryoneedles. The cryoneedle can be cooled or heated due to expansion ofthe cryogas, thereby freezing or thawing tissue in the vicinity of thecryoneedle.

SUMMARY

Certain embodiments include a cryoneedle comprising an outer tube havinga distal section. The cryoneedle has a gas supply line positionedcoaxially within the outer tube. The gas supply line can be configuredto supply a cryogas for forming an ice ball on an outer surface of theouter tube over the distal section. The cryoneedle can have an expansionchamber placed within the distal section such that the central gassupply line terminates in the expansion chamber. The cryoneedle can havea heat exchange helix contacting the inner surface of the outer tube.The cryoneedle can have a return gas flow lumen defined annularlybetween the heat exchange helix and the central gas supply line adaptedto carry cryogas from the expansion chamber toward the proximal section.The heat exchange helix can provide generally uniform cooling in thedistal section such that the iceball is generally symmetric in shape.

In certain embodiments the heat exchange helix has an increasing surfacearea per unit distance of the distal section such that the iceball has agenerally symmetric shape. In some cases, the return gas lumen providesa helical return path for the cryogas from the expansion chamber towardthe proximal section.

Certain embodiments include a method of forming symmetric iceballsduring cryosurgery. The method can comprise providing a cryosurgerysystem comprising a cryoneedle such as those described herein. Themethod involves supplying a cryogas through the gas supply line,expanding the cryogas at the expansion chamber, providing a helicalreturn path for cryogas in the distal section, wherein the cryogas flowsin the return gas flow lumen in a direction from the expansion chambertoward a proximal section, and forming an iceball on an outer surface ofthe outer tube over the distal section such that the iceball has agenerally symmetric shape.

BRIEF DESCRIPTION OF DRAWINGS

The following drawings are illustrative of particular embodiments of thepresent invention and therefore do not limit the scope of the invention.The drawings are not necessarily to scale (unless so stated) and areintended for use in conjunction with the explanations in the followingdetailed description. Embodiments of the invention will hereinafter bedescribed in conjunction with the appended drawings, wherein likenumerals denote like elements.

FIG. 1A is a perspective view of a cryoneedle according to anembodiment;

FIG. 1B is an enlarged perspective view of portion 1B of the cryoneedleshown in FIG. 1A;

FIG. 2 is an enlarged cross-sectional front view of portion 3 of thecryoneedle shown in FIG. 1A taken along the plane 2-2;

FIG. 3 is an enlarged perspective view of portion 3 of the cryoneedleshown in FIG. 1A with the outer tube removed from the view to illustrateinternal components housed therein;

FIG. 4 is a cross-sectional view of the cryoneedle shown in FIG. 3 takenalong the plane 4-4;

FIG. 5 is an enlarged perspective view of portion 5 of the cryoneedleshown in FIG. 1A with the outer tube removed from the view to illustrateinternal components housed therein;

FIG. 6 is an enlarged perspective view of portion 6 of the cryoneedleshown in FIG. 2 ;

FIG. 7A is a front view of a cryoneedle according to certain embodimentsillustrated with an ellipsoidal iceball formed at its distal tip; and

FIG. 7B is a front view of a cryoneedle according to certain embodimentsillustrated with a spherical iceball formed at its distal tip.

DETAILED DESCRIPTION

The following detailed description is exemplary in nature and is notintended to limit the scope, applicability, or configuration of theinvention in any way. Rather, the following description provides somepractical illustrations for implementing exemplary embodiments of thepresent invention. Examples of constructions, materials, dimensions, andmanufacturing processes are provided for selected elements, and allother elements employ that which is known to those of ordinary skill inthe field of the invention. Those skilled in the art will recognize thatmany of the noted examples have a variety of suitable alternatives.

Cryosurgical systems can be used for cryoablating target tissues (e.g.,a tumor). Typically, such systems include one or more cryoneedles, oneor more cryogas sources and a controller. The cryogas sources can supplygases such as argon, nitrogen, air, krypton, CO2, CF4, xenon, andvarious other gases. The cryosurgical system can also include acontroller having one or more sensors, flow meters, timers,analog/digital converters, wired or wireless communication modules, etc.Additionally, the controller can also regulate the flow rate,temperature and pressure of cryogas supplied to the cryoneedle.

During cryosurgery, for instance, a surgeon may deploy one or morecryoneedles such as those illustrated in FIG. 1 to cryoablate a targetarea of a patient anatomy by placing the cryoneedle 10 at or near thetarget area of the patient anatomy. In one example, cryoneedle 10utilizes the Joule-Thomson effect to produce cooling or heating. In suchcases, a cryogas expands in the cryoneedle 10 from a higher pressure toa lower pressure. Expansion of the cryogas results in temperatures at orbelow those necessary for cryoablating a tissue in the vicinity of thetip of the cryoneedle 10. Heat transfer between the expanded cryogas andthe outer walls of the cryoneedle 10 can be used to form an iceball, andconsequently cryoablate the tissue.

As shown in FIGS. 1A-1B and 2 , components of the cryoneedle 10 arelocated within an outer tube 12 (e.g., a trocar). The outer tube 12 canhave a distal operating head 16 disposed at a distal section 20 of thecryoneedle 10 for penetrating through tissues of a patient duringdeployment. The outer tube 12 can be of substantially thin cross sectionfor allowing deployment in tissues of a patient. In one example, theouter tube 12 has an outer diameter of about 2.1 millimeters. Otherdimensions of the outer tube 12 are also contemplated. For example, theouter tube 12 can have an outer diameter of between about 1.5millimeters and about 2.4 millimeters. As mentioned above, the outertube 12 can have a distal section 20 placed at or near a target area ofa patient's anatomy. The outer tube 12 can also have a middle section 24positioned between the distal section 20, and a proximal section 30 ofthe cryoneedle 10. Additionally, the outer tube 12 has a longitudinalaxis 34.

As seen in FIG. 2 , the cryoneedle 10 includes a gas supply line 38extending substantially along its length for providing a high-pressuregas to the distal operating head 16. The gas supply line 38 can bepositioned coaxially/concentrically within the outer tube 12. The gassupply line 38 can be configured to supply a cryogas for formingiceballs on an outer surface 40 of the outer tube 12 over the distalsection 20. In some cases, the gas supply line 38 can be a capillarytube. Referring to FIG. 1B, the gas supply line 38 comprises a proximalheat exchanger 50 positioned in the proximal section 30 of thecryoneedle 10 and operably connected to a cryogas source (not shown) ata first end 52 and the capillary tube at a second end 54. The proximalheat exchanger 50 can precool the cryogas from the cryogas source priorto being delivered to the middle and/or distal sections.

With continued reference to FIG. 1B, the proximal heat exchanger 50 canbe a hollow helical tube 56 wound around a central core 58. The helicaltube 56 of the proximal heat exchanger 50 provides increased heatexchange surface area per unit length of the helical tube 56 incomparison to heat exchangers that are not coiled. The helical tube 56can be made of brass. Other metals such as stainless steel are alsocontemplated. In the illustrated embodiment shown in FIG. 1A, theproximal heat exchanger 50 is positioned far from the distal operatinghead 16. For instance, the proximal heat exchanger 50 can be positionedat a handle (not shown). In such cases, an insulating outer cover (notshown) can be positioned over the proximal heat exchanger 50 so as tofacilitate manual deployment (e.g., by grasping the handle) by anoperator (e.g., a surgeon). The insulating outer cover can be made ofheat shrink plastic film. In some cases, the central core 58 can besubstantially rigid in comparison to the distal operating head 16. Suchembodiments can be beneficial in providing a cryoneedle 10 with asubstantially flexible distal operating head 16 for penetrating softtissue and a substantially rigid handle having a proximal heat exchanger50 to precool the cryogas.

Referring to FIG. 2 , the distal section 20 can have a first portion 60and a second portion 70. The cryoneedle 10 can include an expansionchamber 72 within the first portion 60 of the distal section 20 suchthat the gas supply line 38 terminates in the expansion chamber 72. Insome cases, the gas supply line 38 (e.g., capillary tube) can terminatein a joule-thomson orifice 74. The joule-thomson orifice 74 can bepositioned near the expansion chamber 72. A high-pressure cryogassupplied via the gas supply line 38 exits gas supply line 38 via thejoule-thomson orifice 74 and expands in the expansion chamber 72. As thecryogas expands in the expansion chamber 72, it cools rapidly and formsiceballs of different shapes and/or sizes over the outer surface 40 ofthe outer tube 12. The expansion of the cryogas can be such that whenexpanded, the cryogas is colder than the incoming cryogas.

With continued reference to FIG. 2 , the cryoneedle 10 comprises areturn gas flow lumen 78 defined annularly between the heat exchangehelix 100 and the central gas supply line 38. The return gas flow lumen78 can carry cryogas from the expansion chamber 72 toward the proximalsection 30 of the cryoneedle 10 along a return flow path 79 shown inFIG. 2 . The return gas flow lumen 78 is defined along a return path ofthe cryogas between the gas supply line 38 and the inner wall 102 of theouter tube 12 of the cryoneedle 10. In certain embodiments as will bedescribed below, the return gas flow lumen 78 is helical in shape.Referring now to FIGS. 4 and 5 , and in operation, the cryogas expandsin the expansion chamber 72, and the expanded cryogas flows in thereturn flow lumen, thereby cooling incoming cryogas flowing through thegas supply line 38. The expanded gas can subsequently be exhausted tothe atmosphere near an end of the outer tube 12.

Referring back to FIG. 2 , in some cases, a heater 80 can optionally beprovided within the outer tube 12 near the distal section 20 tofacilitate disengagement of cryoneedle 10 after cryoablating a tissue,for thawing a tissue at or near the distal section 20 of the cryoneedle10, for cauterizing tissues, or for other purposes. As illustrated inthis exemplary embodiment, an electrical heater 80 is provided coaxiallywith the gas supply line 38 and the outer tube 12 to facilitate heatingthe distal section 20 of the cryoneedle 10. Alternatively, theelectrical heater 80 can be positioned elsewhere in cryoneedle 10 toheat the distal section 20 of the cryoneedle 10. The electrical heater80 can be a resistive heater, wherein the electrical heater 80 generatesheat proportional to the current flow therethrough and the electricalresistance of electrical heater 80. In such cases, as alluded topreviously, the controller (not shown) can supply and/or regulate (e.g.,with a Wheatstone bridge, ampere meter or voltmeter) electrical currentflow to the electrical heater 80 within the cryoneedle 10. In theembodiment illustrated in FIG. 2 , the electrical heater 80 comprisesmetal wires (e.g., copper) wound in helical coils (e.g., between about50 coils and about 200 coils) around the gas supply tube. For instance,the wires are wound with a negligible pitch between adjacent coils ofthe wire. Additionally, the wires can substantially contact an outersurface 40 of the gas supply tube. While an electrical heater 80 isillustrated herein, alternative methods of heating the distal section 20of the cryoneedle 10 are contemplated. For instance, the distal section20 can instead be heated using a heating gas (e.g., a cryogas having aninversion temperature lower than temperature obtained by liquefaction ofcooling gas) such as high-pressure helium supplied by a cryogas source.Alternatively, the distal section 20 of the cryoneedle 10 may not beheated and/or surrounding may not be tissue thawed.

As mentioned previously, the temperature of the cryogas can be colder inthe first portion 60 of the distal section 20 (due to Joule-Thomsoneffect), than in the second portion 70, and heat transfer between thecryogas and the outer tube 12 can be higher over the first portion 60than in the second portion 70. This can result in an iceball having anasymmetric shape (e.g., pear-shaped with the iceball generally taperingtoward the second portion 70). To prevent asymmetric iceball formation,as seen in FIGS. 2 and 3 , in one example, the cryoneedle 10 includes aheat exchange helix 100, comprising coils configured for enhancing heatexchange between the cryogas and the outer tube 12. The heat exchangehelix 100 contacts the inner wall 102 of the outer tube 12 and ispositioned coaxially with the outer tube 12. As perhaps best seen inFIG. 2 , the coils of the heat exchange helix 100 are in contact withthe inner wall 102 of the outer tube 12 and do not contact the heater 80or the gas supply line 38 (e.g., capillary tube). These coilseffectively act as fins on the inner wall 102 of the outer tube 12 andimprove heat transfer to the outer tube 12 to form iceballs havingsymmetric shapes wherein the symmetry is about the longitudinal axis 34of the outer tube 12.

With continued reference to FIGS. 2 and 3 , the presence of heatexchange helix 100 on the inner wall 102 of the outer tube 12 increasesthe surface area over which return gas flows over from the expansionchamber 72 and toward the proximal section 30 of the cryoneedle 10.Moreover, the cryogas flows along a helical path from the expansionchamber 72 toward the proximal section 30 of the cryoneedle 10 resultingin enhanced heat exchange. Such embodiments result in higher heattransfer between the expanded cryogas and the outer tube 12,consequently providing a desired iceball shape and size (e.g., asymmetric shape such as sphere or ellipsoid) as will be described below.The heat exchange helix 100 enhances heat transfer over the distalsection 20 by increasing surface area over which heat transfer occursfrom the cryogas to the outer tube 12 of the cryoneedle 10. For example,the heat exchange helix 100 can provide a heat exchange surface area atthe distal section 20 and permits heat transfer between the cryogas andthe outer tube 12 such that the outer tube 12 is evenly cooled to atemperature of about −150 degree Celsius when the cryogas temperature isabout −155 degree Celsius. Other temperatures are also contemplated. Forinstance, the outer tube 12 can be cooled to any temperature in therange of between about −145 degree Celsius and about −150 degreeCelsius, when the cryogas temperature is between about −155 degreeCelsius and about −150 degree Celsius.

The heat exchange helix 100 can provide generally uniform cooling overthe entire length 104 of the distal section 20 such that the iceball(best illustrated in FIGS. 7A and 7B) is generally symmetric in shape.For instance, the heat exchange helix 100 can facilitate cooling theouter tube 12 evenly over the entire length 104 of the distal section 20such that the heat transfer rate between the cryogas and the outer tube12 is approximately constant over the entire length 104 of the distalsection 20. As mentioned previously, the cryogas flowing in the returnflow lumen over the first portion 60 can be at a lower temperature thanthe cryogas flowing in the return flow lumen over the second portion 70because of rapid expansion of the cryogas near the Joule Thomson orificeand associate rapid cooling that occurs at the first portion 60. In suchcases, the heat exchange helix 100 can increase heat transfer betweencryogas and the outer tube 12 over the second portion 70 such that theheat transfer rate between the cryogas and the outer tube 12 over thefirst portion 60 roughly equals the heat transfer rate between thecryogas and the outer tube 12 over the second portion 70. Suchembodiments can facilitate in generating iceballs having symmetricshape, and prevent formation of iceballs having asymmetric shapes (e.g.,pear-shaped).

As seen in FIG. 3 , the heat exchange helix 100 has a helix pitch. Thehelix pitch can be configured to generate an iceball 150 having asymmetrical shape (e.g., ellipsoidal or spherical). For example, asillustrated, the coils can have variable helix pitch. In FIG. 3 , twohelix pitches are shown: a first pitch 108 over the first portion 60 ofthe distal section 20 and a second pitch 110 over the second portion 70of the distal section 20. The first pitch 108 can be greater than thesecond pitch 110 such that adjacent coils of the heat exchange helix 100are spaced further apart in the first portion 60 than in the secondportion 70. For instance, the heat exchange helix 100 can have fewercoils per unit length in the first portion 60 than in the second portion70. In the illustrated embodiment, the heat exchange helix 100 has ahigher surface area per unit length in the second portion 70 of thedistal section 20 in comparison to the surface area per unit length inthe first portion 60 of the distal section 20. As the cryogas has ahigher temperature in the second portion 70 than in the first portion60, the increased surface area in the second portion 70 facilitates heattransfer rates between the cryogas and the outer tube 12 that is roughlyequal so that the iceball 150 (best illustrated in FIGS. 7A and 7B) hasa generally symmetric shape. Alternatively, the helix pitch can beconstant over the entire length 104 of the distal section 20.

In the embodiments illustrated herein, the heat exchange helix 100 is acoiled spring. The heat exchange helix 100 can be made of tin coatedcopper. Other metals and alloys (e.g., stainless steel) havingsufficient resiliency and/or malleability so as to be formed into ahelical shape of desired helix pitch are also contemplated.

Referring back to FIG. 2 and referring now to FIG. 4 , the cryoneedle 10comprises an insulating sheath 120 positionable at locations other thanthe distal section 20. The insulating sheath 120 abuts against the outertube 12 to prevent the expanded cryogas returning from the expansionchamber 72 from coming into contact with the outer tube 12. For example,the cold return gas avoids contact with areas of the patient's bodyother than intended the target area such that an iceball 150 istherefore formed in the exposed region of the outer tube 12 (e.g.,regions of the outer tube 12 not having the insulating sheath 120positioned between the outer tube 12 and the return gas flow lumen 78).In the illustrated embodiment shown in FIG. 2 , the entire length 104 ofthe distal section 20 is exposed. Over this exposed region length 140,the expanded cryogas contacts the outer tube 12 of the cryoneedle 10 andforms an iceball 150. The insulated sheath is positioned over the entirelength of the middle section 24 of the cryoneedle 10 in this embodiment.Over the entire length of the middle section 24, the cryogas isprevented from contacting the outer tube 12, thereby preventing coolingof tissue surrounding the middle section 24 and/or iceball formationthereon.

In some cases, the exposed region length 140 (best seen in FIG. 2 ) ofthe outer tube 12 can determine the shape of the iceball. FIGS. 7A and7B for instance illustrate an ellipsoidal and a spherical iceball 150formed over the distal section 20 of the cryoneedle 10, respectively. Inone example, when the exposed region length 140 of the outer tube 12 isabout 34 millimeters, the iceball 150 can have a substantiallyellipsoidal shape such as that illustrated in FIG. 7A. In anotherexample, when the exposed region length 140 of the outer tube 12 isabout 18 millimeters, the iceball 150 can have a substantially sphericalshape such as that illustrated in FIG. 7B. While in both FIGS. 7A and7B, the iceball 150 formed is of a symmetric shape, the exposed regionlength 140 of the outer tube 12 (e.g., not covered by the insulatingsheath 120) influences the aspect ratio 160 of the iceball 150 shape.For example, a shorter exposed region length produces a sphericaliceball 150 and a longer exposed region length produces an ellipsoidaliceball. By shortening or extending the length of the insulating sheath120, various symmetric shapes can be obtained. The exposed region length140 can thus be varied to change an aspect ratio 160 of the iceball 150.As illustrated in FIGS. 7A and 7B, aspect ratio 160 of the iceball 150can be defined as the ratio of length 162 of the iceball 150 measuredalong the lengthwise direction of the cryoneedle 10 and the width 164 ofthe iceball 150 measured in a direction perpendicular to the lengthwisedirection of the cryoneedle 10. As illustrated, an aspect ratio 160 ofabout one implies a spherical iceball 150.

In some exemplary cases, the heat exchange helix 100 disclosed hereincan create additional resistance to flow of expanded cryogas in thereturn gas flow lumen 78. In such cases, the dimensions of thecryoneedle 10 can be configured to prevent excessive flow resistanceand/or back pressure being generated in the cryoneedle 10. Referring nowto FIGS. 5 and 6 , the insulating sheath 120 can have dimensionssuitable to permit the return flow of expanded cryogas from the distalsection 20 toward the proximal section 30. For instance, the insulatingsheath 120 can have an inner diameter 170 sufficient to create anannular gap between the gas supply line 38 and an outer wall of theinsulating sheath 120 as best seen in FIGS. 5 and 6 . The annular gapbeing in fluid communication with the return gas flow lumen 78 toreceive cryogas flowing therethrough. In one example, the inner diameter170 of the insulating sheath 120 is about 1.32 mm. In other examples,the insulating sheath 120 can have an inner diameter 170 between about0.5 millimeters and about 2 millimeters. In one example, when the outerdiameter of the outer tube 12 is about 2.1 millimeters, the insulatingsheath 120 can have an inner diameter 170 of between about 1.0millimeter and about 1.4 millimeters. In another example, when the outerdiameter of the outer tube 12 is about 1.5 millimeters, the insulatingsheath 120 can have an inner diameter 170 of about 0.72 millimeters. Inanother example, when the outer diameter of the outer tube 12 is about2.4 millimeters, the insulating sheath 120 can have an inner diameter170 of between about 1.25 millimeters and about 1.7 millimeters. Theinner diameter 170 of the insulating sheath 120 can therefore besufficiently large to minimize back pressure acting on the expandedcryogas flowing through the annular gap from the return gas flow lumen78. In such cases, backpressure is minimized to allow the pressure ofthe expanding cryogas to fall as low as possible (e.g., zero gauge),which results in a lower gas temperature and bigger iceball. Maximizingthe inner diameter 170 of the insulating sheath 120 helps to minimizethe overall backpressure of the cryoneedle 10.

Certain embodiments include a method of forming ice balls having asymmetric shape during cryosurgery. The method can comprise the step ofproviding a cryosurgery system such as those disclosed herein, supplyinga cryogas through the gas supply line 38, expanding the cryogas in theexpansion chamber 72, providing a helical return path for cryogas in thedistal section 20, the cryogas flowing in the return gas flow lumen 78in a direction from the expansion chamber 72 toward a proximal section30, and forming an iceball 150 on an outer surface 40 of the outer tube12 over the distal section 20 such that the iceball 150 has a generallysymmetric shape.

Embodiments of the cryoneedle 10 disclosed herein can provide severaladvantages. The cryoneedle 10 can be configured such that substantiallysymmetric iceballs having desirable shapes. The cryoneedle 10 canenhance heat transfer over portions of its distal section 20 such thatdesirable iceball characteristics (e.g., symmetry, size and shape) canbe obtained with a smaller needle outer tube 12 diameter. Moreover,because of the smaller needle outer tube 12 diameter, the weight andtorque on the needle handle are also minimized making the cryoneedle 10easily deployable during cryosurgery.

Thus, embodiments of cryoneedle 10 with evenly distributed cooling aredisclosed. Although the present embodiments have been described inconsiderable detail with reference to certain disclosed embodiments, thedisclosed embodiments are presented for purposes of illustration and notlimitation. One skilled in the art will appreciate that various changes,adaptations, and modifications may be made without departing from thespirit of the invention.

What is claimed is:
 1. A cryoneedle comprising: an outer tube having alongitudinal axis and a distal section for placing at or near a targetarea of a patient's anatomy; a gas supply line positioned within theouter tube, the gas supply line configured to supply a cryogas forforming an iceball on an outer surface of the outer tube at the distalsection; an expansion chamber located within the distal section, the gassupply line terminating in the expansion chamber; a return gas flowlumen configured to carry expanded cryogas away from the expansionchamber in the distal section and toward a proximal section of the outertube, an electrical heater positioned coaxially with the gas supply lineand the outer tube, wherein the electrical heater comprises a metal wirewound in helical coils around and in contact with an outer surface ofthe gas supply line; and a heat exchange helix disposed within thedistal section and in contact with an inner surface of the outer tube,the heat exchange helix defining a portion of the return gas flow lumenannularly between the heat exchange helix and the gas supply line,wherein the cryogas is adapted to flow between helices of the heatexchange helix from the expansion chamber along a return flow path,wherein the heat exchange helix along the heat exchange helix has afirst pitch over a first portion of the distal section and a secondpitch over a second portion of the distal section, wherein the firstportion is distal of the second portion, and wherein the first pitch isgreater than the second pitch such that a heat transfer rate between thecryogas and the outer tube is approximately constant over an entirelength of the distal section, the heat exchange helix thereby providinga generally uniform rate of heat transfer in the distal section suchthat the iceball formed on the outer surface of the outer tube isgenerally symmetric in shape along the longitudinal axis of the outertube.
 2. The cryoneedle of claim 1, further comprising an insulatingsheath dividing the outer tube into a proximal insulated region and adistal non-insulated region, wherein the electrical heater is anelectrical resistance heater that is both disposed about the gas supplyline and within the distal non-insulated region.
 3. The cryoneedle ofclaim 1, wherein the heat exchange helix is positioned coaxially with anaxis of the outer tube.
 4. The cryoneedle of claim 1, wherein the outertube has an outer diameter of about 2.1 millimeters.
 5. The cryoneedleof claim 1, wherein the gas supply line terminates in a Joule-Thomsonorifice within the expansion chamber, the expansion chamber beingadapted to expand the cryogas exiting the Joule-Thomson orifice, and thereturn gas flow lumen being adapted to pass the expanded cryogas overthe gas supply line thereby cooling incoming cryogas in the gas supplyline.
 6. The cryoneedle of claim 1, wherein the heat exchange helix is ahelical wire.
 7. The cryoneedle of claim 1, further comprising aninsulating sheath substantially surrounding the gas supply line andthereby forming a barrier between the return gas flow lumen and theouter tube over a portion of a length of the outer tube.
 8. Thecryoneedle of claim 7, wherein the insulating sheath comprises an innertubular wall and an outer tubular wall.
 9. The cryoneedle of claim 8,wherein the outer tubular wall of the insulating sheath is in contactwith the outer tube.
 10. The cryoneedle of claim 8, wherein an annulargap is defined between the gas supply line and the inner tubular wall ofthe insulating sheath the annular gap being in fluid communication witha distal portion of the return gas flow lumen such that the return gasflow lumen receives the cryogas therethrough.
 11. The cryoneedle ofclaim 10, wherein the annular gap defined between the outer tubular wallof the insulating sheath and the gas supply line has a diametersufficient to minimize back pressure acting on the expanded cryogasflowing through the annular gap from the return gas flow lumen.
 12. Thecryoneedle of claim 7, wherein an inner diameter of the insulatingsheath is about 1.32 mm.
 13. The cryoneedle of claim 7, wherein theinsulating sheath surrounds the gas supply line over a portion of thelength of the outer tube such that the expanded cryogas directlycontacts the outer tube over an exposed region, the exposed regionhaving an exposed region length, the exposed region length adapted togenerate the iceball having a predetermined aspect ratio.
 14. Thecryoneedle of claim 1, wherein the gas supply line is coaxial with thelongitudinal axis of the outer tube.
 15. The cryoneedle of claim 1,further comprising a heat exchanger positioned in a proximal section ofthe cryoneedle.
 16. The cryoneedle of claim 15, wherein the heatexchanger comprises a helical tube.
 17. The cryoneedle of claim 1,wherein the heat exchange helix has a heat exchange surface area at thedistal section, the heat exchange surface area provides heat transferbetween the cryogas and the outer tube such that the outer tube iscooled to a temperature of between about −150 degree Celsius and about−145 degree Celsius when a temperature of the cryogas is about −155degree Celsius and about −150 degree Celsius respectively.
 18. Thecryoneedle of claim 1, wherein the expansion chamber is adapted toexpand the cryogas, and the expanded cryogas flowing in the return gasflow lumen is adapted to cool incoming cryogas flowing through the gassupply line.
 19. The cryoneedle of claim 1, wherein the electricalheater is positioned near the distal section.